Corporate Banner
Satellite Banner
Molecular & Clinical Diagnostics
Scientific Community
Become a Member | Sign in
Home>News>This Article

Lab21 Among First to Offer FDA Approved Companion Diagnostic in the US

Published: Monday, July 16, 2012
Last Updated: Monday, July 16, 2012
Bookmark and Share
CLIA laboratory to provide guidance for the use of Erbitux®.

Lab21 Limited has announced that its CLIA laboratory in Greenville, South Carolina, has been named as one of nine laboratories in the US to offer the first FDA approved companion diagnostic test to provide guidance for the use of Erbitux® (cetuximab).

Recent FDA approval of the Qiagen therascreen KRAS test, allows it to be used to determine whether patients with metastatic colorectal cancer are suitable for treatment with Erbitux.

The test has been routinely used in Europe since 2008 and is the first KRAS assay to secure FDA approval.

The availability of this test gives healthcare providers an FDA approved test which provides fast, consistent and reliable data to determine optimal treatment for colorectal cancer patients who are candidates for EGFR-targeted inhibitor therapy.

Lab21 has been providing a KRAS analysis service using the assay from its CPA Accredited laboratory in Cambridge, UK for both Amgen and Merck Serono since 2008, and has performed in excess of 6000 tests during this time, including patient samples originating in a number of countries in Europe and the Middle East.

Michael Bolick, President of Lab21 Inc., commented: “Lab21 Inc. is delighted to have launched the therascreen KRAS assay as part of our initial portfolio of molecular diagnostic tests. As the only laboratory in Qiagen’s launch group based in the South-eastern region of the US market, Lab21 is well positioned to be the first provider of this valuable service to the regional cancer community.”

Mike Annable, Divisional Director - Clinical Laboratory, added, “Lab21 has significant clinical experience with the therascreen KRAS assay having been one of the first commercial labs to provide this validated assay in the UK. We have been able to leverage this experience during the laboratory validation of the assay for the US market and we are pleased that Erbitux patients can benefit from this experience.”

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,800+ scientific posters on ePosters
  • More than 4,000+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Lab21 Partners with Top 10 IVD Player
Agreement to develop, manufacture and distribute new Aspergillus molecular assay.
Wednesday, April 11, 2012
Lab21 Announces Appointment of Industry Expert Fraser Logue
Dr Logue joins Lab21 team as Group Director of Quality, Regulatory Affairs & Operations Excellence.
Tuesday, February 21, 2012
Scientific News
Mathematical Model Forecasts the Path of Breast Cancer
Chances of survival depend on which organs breast cancer tumors colonize first.
Measuring microRNAs in Blood to Speed Cancer Detection
A simple, ultrasensitive microRNA sensor holds promise for the design of new diagnostic strategies and, potentially, for the prognosis and treatment of pancreatic and other cancers.
Biomedical Imaging at One-Thousandth the Cost
Mathematical modeling enables $100 depth sensor to approximate the measurements of a $100,000 piece of lab equipment.
Improving Outcomes for Lung Cancer and Diabetic Patients
Novel technologies have been developed with support from SBRI Healthcare funding.
New Way of Detecting Cancer
A new RNA test of blood platelets can be used to detect, classify and pinpoint the location of cancer by analysing a sample equivalent to one drop of blood.
Rapid, Portable Ebola Diagnostic
Scientists confirmed the efficiency of the novel Ebola detection method in field trials.
New, Better Test for Prostate Cancer
A study from Karolinska Institutet shows that a new test for prostate cancer is better at detecting aggressive cancer than PSA.
Blood Test Picks Out Prostate Cancer Drug Resistance
Scientists have developed a blood test that can identify key mutations driving resistance to a widely used prostate cancer drug, and identify in advance patients who will not respond to treatment.
Antibody Targets Key Cancer Marker
University of Wisconsin-Madison researchers have created a molecular structure that attaches to a molecule on highly aggressive brain cancer and causes tumors to light up in a scanning machine.
Key Piece of MRSA Vaccine Puzzle
New research funded by the Health Research Board and the Wellcome Trust has pinpointed immune cells that could be targeted by an MRSA vaccine.
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos